ENSIZOR

Basic Information

• Brand Name: ENSIZOR
• Primary DI: M707ES26165
• Version / Model: ES26165
• Catalog Number: ES26165
• Company Name: SLATER ENDOSCOPY LLC
• Labeler DUNS: 090101258
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-08-23
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: 5c6ca343-f7a7-459b-afe4-9c370a9d05a6

Device Description

The Slater Endoscopy Ensizor flexible endoscopic scissors is a single-use flexible device used in combination with a dedicated 2.8 mm, minimum channel size endoscope, and is intended to cut tissue or sutures during an endoscopic procedure. It is constructed of a flexible metal coil whose distal end is equipped with a pair of cutting blades operated through a control handle at the proximal end. It is introduced into the body cavity through the working endoscope through the working channel of the endoscope The cutting blades are 2.6 mm in diameter with an insertion length of 165 cm.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: Yes
• Sterilization Methods: Ethylene Oxide

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
OCZ	Endoscopic Grasping/Cutting Instrument, Non-Powered	Gastroenterology, Urology	876.1500	2

GMDN Terms

Code	Name	Definition	Implantable	Status
46420	Flexible endoscopic scissors, single-use	A flexible device used in combination with a dedicated endoscope and intended to cut tissue or sutures during an endoscopic procedure. It is typically constructed of a flexible metal coil or plastic tube whose distal end is equipped with a pair of cutting blades operated through a control handle at the proximal end. It is introduced into the body cavity through the working channel of the endoscope. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	M707ES26165	HIBCC
Package	M707ES261651	HIBCC	Box	3	In Commercial Distribution
Package	M707ES261650	HIBCC	Single Package	1	In Commercial Distribution

Customer Contacts

• Phone: [phone]
• Email: [email protected]
• Phone: [phone]
• Email: [email protected]

Device Sizes

Type	Value	Unit	Text
Length	165	Centimeter
Outer Diameter	2.6	Millimeter